Aliso Viejo, CA – November 23, 2020 –
ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, announced that it has successfully completed Medical Device Single Audit Program (MDSAP) certification and ISO 13485:2016 audits, with no open findings.
MDSAP is a program that allows for one regulatory audit of a medical device manufacturer’s quality management system (QMS) that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized by the participating Regulatory Authorities to audit under MDSAP requirements. Certification allows medical device manufacturers to be audited once for compliance with regulatory requirements for four additional medical device markets outside of the United States: Australia, Brazil, Canada, and Japan.
“MDSAP certification validates ExsoMed’s ongoing commitment to maintaining the highest quality assurance standards within the medical device industry as required by regulatory bodies across the world,” said Daniel Mickelsen, ExsoMed’s Chief Operating Officer. “We are very proud of our team for this significant accomplishment.”
“With ExsoMed’s products experiencing tremendous success in the United States, many hand surgeons and distributors from the international marketplace have also requested our innovative offerings,” shared James Young Kim, ExsoMed’s Managing Director of Global Sales and Marketing. “MDSAP certification now allows us to enter some of the most important healthcare markets in the world and raise the standard of care in hand surgery for their patients, surgeons, and facilities. We are looking forward to sharing more international updates in the coming months.”
ExsoMed is a privately held medical device company providing orthopaedic surgeons with innovative solutions in hand surgery. We believe that our solutions raise the standard of care in hand surgery by providing state of the art surgical tools that streamline use in the operating room, reduce the global cost of care, and enhance outcomes so that patients can get back to life faster.
ExsoMed™ and INnate™ are trademarks of ExsoMed Corporation.